Package of pharmaceutical composition and the like molded in situ



April 3, 1962 c. NICOLLE PACKAGE OF PHARMACEUTICAL COMPOSITION AND THELIKE MOLDED IN SITU 2 Sheets-Sheet 1 Filed June 50, l958 A 7 bal April3, 1962 c. NICOLLE 3,028,002

PACKAGE OF PHARMACEUTICAL COMPOSITION AND THE LIKE MOLDED IN SITU FiledJune 30, 1958 2 Sheets-Sheet 2 9 a fig. .9

United States Patent 3,028,002 PACKAGE 0F PHARMACEUTICAL COMPOSITION ANDTHE LIKE MOLDED IN SITU Charles Nicolle, 54 Ave. Foch, Paris, FranceFiled June 30, 1958, Ser. No. 745,751 Claims priority, applicationFrance July 1, 1957 2 Claims. (Cl. 206-631) This invention relates tothe production of packages of moldable compositions, especiallypharmaceutical compositions, which are molded in situ i.e. within thepacking means in. which they are dispensed. The invention moreespecially relates to the production of suppositories, though it is byno means restricted thereto.

It is already known to mold suppositories and the like directly withinthe packing means in which they are eventually delivered to the market,by pouring metered amounts of the fluid or semi-fluid composition intore ceptacles having the desired inner configuration of the finalsuppositories, whereby such receptacles serve both as the molding andthe packing means for the finished articles. However, such procedure asheretofore used has a number of drawbacks which it is a general objectof the present invention to overcome.

Heretofore the means serving both as the molds and the packing means forsuch articles were sometimes pro vided in the form of a single unitaryreceptacle having a top opening through which the fluid composition waspoured, and a flat strip sealing this opening. Such a form of packingmeans was satisfactory where the molded article or suppository had asimple ogee-like configuration, i.e. av cylindrical body tapered to apoint at one end. However, where the molded article is to have atorpedolike configuration, i.e. having an intermediate diameter largerthan the diameter at either end, as is frequently required, a packingmold of the kind just referred to is unsuitable because the articlecannot then be readily withdrawn out of the packing. In such cases,three-part packing molds have had to be used, including a two-part bodysection or main receptacle separable either in an axial or a transversedirection, and a flat end cover. This three-part construction hasgreatly complicated the manufacturing process. An object of theinvention therefore, is to provide a form of combined molding-andpackingmeans for articles of the type described, which will be in two parts forsimplified production and yet will allow of easily extracting thefinished article from its packing even in cases where said article is ofthe torpedolike shape specified above.

Other objects are to provide packages of composition molded in situ,which will be easier and more economical to produce in large quantities,will contain more accurately metered amounts of composition per package,will be more uniformly and perfectly sealed for prolonged, storage life,and handier to use, as compared to similar products of the prior art.Objects of the invention also relate to methods of producing suchimproved packages.

In accordance with an important aspect of the inven tion, there isprovided a package of molded composition comprising a pair ofreceptacles each sealed at one end and open at the other, one receptaclefitted into the other to define therewith a sealed mold cavity, and abody of said composition molded in situ within said cavity.

In accordance with another aspect, there is provided a method ofpreparing finished packages of molded composition comprising, relativelydisplacing a linear array of upwardlyopen first receptacles successivelypast overhead metering and sealing stations, feeding a metered amount ofsaid composition in fluid or semi-fluid state into each first receptacleas it is positioned under a metering sta tion, inserting adownwardly-open second receptacle into each filled first receptacle asthe latter is positioned under 3,028,002 Patented Apr. 3, 1962 a sealingstation so that said. composition fills thel free spaces defined betweensaid first and second receptacles, said second receptacles having topvents for discharge of air from said spaces, and allowing said meteredamounts of composition to set within said spaces to provide the finishedpackages.

The above and further objects, features and advantages of the inventionwill appear from the, ensuing description relating exemplary embodimentsof the invention selected for illustrative purposes but not forlimitation, with reference to the accompanying drawings, wherein:

FIGURE 1 is sectional view of the body member of a packing moldaccording to the invention containing the metered amount of compositionfilling the member to a predetermined height;

FIGURE 2 is a view similar to FIGURE 1, after insertion thereinto of asleeve member according to the invention;

FIGURE 3 is a partial view showing a modification of FIGURE 2 on anenlarged scale;

FIGURE 4 is similar to FIGURE 2 but relates to another modification;

FIGURE 5 is a highly simplified view of apparatus for performing themolding and sealing process of the invention according to one formthereof;

FIGURE 6 is similar to FIGURE 2 but relates to another modificationwherein the composition is introduced into the body member of thepacking mold in the form of a cylindrical slug or paste-likeconsistency;

FIGURE 7 is a highly schematic view of apparatus for filling the bodymembers of the packing molds in accordance with the method of FIGURE 6;

FIGURE 8 is an axial view of another form of packing mold according tothe invention filled with a metered amount of composition, before theshaping sleeve has been pushed in;

FIGURE 9 is a view similar to FIGURE 6 showing the components in theirfinal position after the product has been shaped;

FIGURE 10 is a sectional view of a modified construction of the upper orend portion of the shaping sleeve;

FIGURE 11 is an overhead plan view of the shaping sleeve shown in FIGURE8;

FIGURE 12 is a sectional view of a modified construction of the bodymember of the packing mold;

FIGURE 13 is a sectional view of another form of the upper part of theshaping sleeve, being generally similar to FIGURE 8;

FIGURE 14 is a plan view of another modified form of the upper portion;and

FIGURE 15 shows part of a bunch of packing molds according to theinvention.

In the illustrated embodiments of the invention to be described,particular reference will be made to the packing of suppositories, andmore particularly still to the packing of suppositories of the torpedotype as earlier defined. It should be expressly understood however thatthe teachings of the invention are essentially applicable to packingmeans for suppositories of other shape, i.e. ovoidal, as well as to awide range of other articles of moldable and shapable character.

As shown in FIGURES 1 and 2, the packing mold according to one form ofthe invention comprises two main components, a first receptacle or bodymember 1, and a second receptacle or shaping and sealing sleeve member3. The body member 1 comprises a generally cylindrical part with anogival bottom end. The inner surface of the body member 1 or firstreceptacle is formed with a shoulder 2 defined at the root of the ogivalportion which is of greater thickness than the cylindrical portion,thereby providing the said shoulder. The shoulder 2 serves to seat thelower end of the sleeve member 3 as shown in FIGURE 2. The sleeve memberor second receptacle 3 has an outer diameter corresponding to the innerdiameter of the cylindrical part of the first receptacle 1, so as to bea friction fit therein. When inserted home so that its lower end isseated against shoulder 2, the inner surface of the second receptacle orsleeve member 3 at its lower end seated against said shoulder,corresponds exactly to the inner diameter of the ogival end portion ofthe first receptacle. The inner diameter of the sleeve 3 then graduallydecreases upwards from its said lower end, for example according to thecontour shown, in order to define an inner free space correspondingexactly in contour to the outer contour of the molded article to beprovided; herein this shape is that of a torpedo -'ke suppository havinga maximum diameter at the shoulder 2.

Formed solid with the upper end of the shaping sleeve 3 is a flatsealing wall 4, so that it will be seen that the shaping member and thesealing member herein constitute an integral unit. A side vent hole isformed at the top of the sleeve to permit discharge of air entrappedbetween the upper surface of the contents and the sealing wall 4, whenthe sleeve 3 is forced into the body 1.

The packing mold described is used in the following way. The product pto be packed, preferably in liquid or semi-liquid form, is poured intothe body member 1 up to a predetermined level n therein, as shown inFIGURE 1, such level being spaced a substantial distance from theuppermost end of the body 1. The shaping and sealing sleeve 3 is theninserted intothe body, whereupon the air escapes through the vent 5 andthe liquid level rises up to the level 12'. At this time the packingoperation is complete, and it is simply necessary to allow the filledpacking mold to cool down so that its contents will set, without anyspecial precautions.

As shown in FIGURE 3, the open upper end of the body part 1 may beformed with a bevel as at 6, or with an equivalent rounded flared orfunnel-like shape to facilitate insertion of the sleeve 3.

A modified construction is shown in FIGURE 4 wherein the inner surfaceof the cylindrical part of the body 1 and the outer surface of thesleeve 3 are formed with a complementary tapered shape preferably overpart of their vertical extent so that, on insertion of sleeve 3 intobody 1, the tapered surface of the sleeve is a tight fit in the taperedsurface of the body.

In FIGURE 5 one arrangement is schematically illustrated for filling thepacking molds of the invention whereby the articles are simultaneouslyshaped and the packing molds sealed. As shown, a set of firstreceptacles 1 of the packing molds e.g. according to the form shown inFIGURE 1, are disposed in a movable frame 7 positioned under a meteringfeeder 8 of conventional type operable, when an empty first receptacleis positioned below it, for introducing a metered dose of fluid orsemi-fluid substance into the first receptacle 1 up to the prescribedlevel n therein. The frame 7 is then shifted in the direction indicatedby the arrow, to bring the filled first receptacle to a positionunderlying a device 9 serving to insert the second receptacles 3 intothe first receptacles 1 over the contents thereof. At the same time, theleftward shifting of the frame 7 has brought the next following firstreceptacle 1 on the frame to a point underlying metering feeder 8 sothat it can be filled simultaneously with the insertion of the secondreceptacle into the previously filled first receptacle by the device 9.This procedure can be repeated any desired number of times.

While the body members 1 of the individual packing molds have so farbeen described and illustrated as elements separate from one another,this is by no means essential and in fact the invention particularlycontemplates that embodiment wherein all the first receptacles 1 areintegrally interconnected. The interconnections may take the form ofconnecting flanges at the upper ends of the body members 1 or connectingstrips extending between the adjacent body members in a common planesuch that it contains the center axes of all the members. Similarly, theshaping and sealing sleeve members 3 may be connected to one anotherrather than being separate as shown e.g. in FIGURE 2. In this manner anintegral bunch may be provided comprising any desired number of similarpacking molds; and if desired frangible areas, such as lines ofperforations or the like, may be provided between the adjacent packingmolds to facilitate tearing them off one by one on demand.

It will be noted in connection with the filling process shown in FIGURE5 that owing to the fact that the contents p filling the body members 1only reaches up to a point short of the upper opening of said member, notrouble is experienced during the successive shifting steps of the frame7 as described above, due to the possibility that would otherwise bepresent of the liquid contents of the body members splashing out as eachnewly filled body member is shifted from filling station 8 to sealingstation 9. If the body members were filled completely as is usually thecase in the prior art, such splash ing would result in loss of substanceand non uniform filling as well as soiling the outer surfaces of thepacking and apparatus. However, if desired either for further preventingsuch splashing or for any other reason, the frame 7 with the moldmembers 1 thereon may be provided stationary, and the units 8 and 9 maybe provided movable instead.

As already mentioned the sleeve member or second receptacle 3 serves thetwofold function of a shaping member, in cooperation with the bodymember 1, and a sealing means. This is advantageous both in that itreduces the number of separate component elements of each packing moldto no more than two, and because it similarly reduces the number ofseparate operations in volved in the molding and packing process, to afilling step and a sealing step. These are characteristic features ofthe invention and result in a greatly increased efiiciency and economyof the molding and packing operations.

An additional advantage achieved through the arrange ment described, isthe excellent seal obtained, due to the integral character of the topflange 4 with the sleeve 3, in contrast with what is had with separatesealing strips as generally used with conventional packing molds of thiskind, wherein the bonding of the strip is apt to be nonuniform andportions of the liquid contents are apt to be lodged between the moldand the sealing strip, especially due to the aforementioned splashingeffect, thereby interfering with proper bonding of the strip.

FIGURE 6 illustrates yet another embodiment wherein the substance prather than being poured in liquid form into the body member 1, isintroduced in the form of a cylindrical slug of paste or pulp. Thesubsequent insertion of the shaping and sealing sleeve 3 into the bodyunder suitable pressure, deforms the semi-solid slug and forces it toits final shape as determined by the body member 1 and sleeve member '3.

A suitable filling or packing arrangement for use with this form of theinvention is shown in FIGURE 7. As shown, a frame 7 is arranged to carrya set of first receptacles 1 of the kind shown in FIGURE 1 or FIG- URE6, and it is here assumed by way of example that all these members areinterconnected together by connecting flanges 8, though the members 1could obviously be separate as shown in FIGURE 5. Overlying the frame isa feeding unit 9 which may comprise any suitable extruding means, anddelivers a predetermined number of cylindrical sausage-like elements 10respectively overlying a corresponding number of the members 1. Suitablemeans such as a wire 11 are provided for cutting off predeterminedlengths of the elements '10 which then drop into the underlyingmembers 1. The frame 7 is then shifted a suitable distance leftward asshown by the arrow so that the newly filled body members 1 are moved toa position underlying a sealing device (not shown) nur- for applying thesleeve members 3 as previously described. The insertion of the sleeves 3is effected at suitable temperature depending on the nature of thecontents to be packed so as to impart to the slug of material p thenecessary plasticity.

It will be understood that, while FIGURE 5 shows a metering and feedingdevice 8 and a sealing device 9 each of which cooperates with only asingle member 1 at a time, and while FIGURE 7 illustrates a feedingdevice 9 oooperating with a plurality of members 1 at a time and whereasthe sealing device (not shown) referred to in connection with thisfigure was also said to cooperate with the same plurality of memberssimultaneously, such arrangements are by no means essential; thus inFIGURE 5 each of the devices 8 and 9 could be of a multiple or manifoldcharacter as the device 9 in FIGURE 7, while in FIGURE 7 the device 9might be arranged to extrude only a single sliver of pasty material.

In the embodiment of the invention shown in FIG- URES 8 and 9, thesecond receptacle or shaping sleeve 3 instead of being thick-walled asso far shown, is made from thin flexible sheet material, such aspolyethylene or the like, so that its outer contour is reduced as wellas its inner contour, rather than being generally cylindrical. Thisembodiment achieves an economy in packing material, and has anotheradvantage in that it facilitates ex-1 pulsion of the contents, e.g.suppository, by finger pressure out of the member 3.

The body member 1 is preferably made of a relatively hard plastic suchas polystyrene or the like, which is inexpensive, though it should beunderstood that it may also if desired be made of flexible sheetmaterial similar to the sleeve member 3. Another advantage of using arelatively hard plastic material for making the body member 1 is tofacilitate the insertion of the sleeve 3 into it without tending todeform the body member 1. In fact the combination of a relatively stiffbody member 1 (e.g. of polystyrene) with a relatively flexible sleevemember 3 (e.g. of polyethylene) provides an especially desirablecombination in that it permits of inserting the sleeve members with theexertion of only very slight pressure. The requisite seal may be assuredby imparting to the sleeve 3 at its lower end an outer diameter slightlylarger than the maximum inner diameter of the body member. As alreadydescribed with reference to an other embodiment, insertion of the lowerend of sleeve 3 into body 1 may be further facilitated by imparting tothe upper end of the body 1 a slightly outwardly flared shape, as shownat e in FIGURE 12, or rounded as shown in FIGURES 8 and 9. These latterfigures also illustrate an annular bead r surrounding the upper end ofbody member 1 which serves to impart increased rigidity to the bodymember as well as facilitating the filling and sealing operations. Itwill be understood that various other modifications of shape may beapplied to the upper end of the body member 1.

Preferably, as shown in FIGURES 8 and 9, the sealed upper end wall a ofthe sleeve member 3 is slightly domed, and is very thin so as to yieldreadily and deform upwards under light finger pressure. This facilitatesexpulsion of the suppository in case it tends to stick to the walls ofthe sleeve 3.

Alternatively to the domed shape just described the upper wall a may betrapezoidal in cross section, i.e. in the shape of a cone frustum, asshown at a in FIGURE 10. Both the vertical depth dimension of the domedwall a and that of the frustoconical wall a may be quite small, and infact said wall can suitably be made flat in those cases where the wallis made from highly flexible sheet material of sufficiently highresiliency, such as polyethylene, and sufliciently low thickness, andeven concave, since pressure exerted on the sides of the sleeve willthen deform said end wall to expel the suppository or the like from thesleeve.

To permit discharge of the air entrapped at b (FIGURE 8) on insertion ofthe sleeve 3, a minute hole 5' may be provided in the end wall a, smallenough so that the air will only be ableto pass through it under theeffect of pressure, specifically the air pressure developed in b oninsertion of the sleeve 3 into the body. After the air has beendischarged from b and both components 1 and 3 are properly positionedwith respect to each other, the orifice 5 is in effect sealed, and asimpenetrable to outside air. Even should the suppository or othercontents of the packing mold happen to melt at any time, it will not beable to flow out through the orifice 5 in view of its extremely smallarea.

Instead of the pinprick orifice 5' the aforementioned vent may beprovided in the form of one or more slotlike incisions 5". There may bea single cut, as in FIG- URE 10, or there may be two crossed cuts as inFIGURE 11 or a greater number forming a star pattern as in FIGURE 14.Oninsertion of the sleeve 3 into body 1 the air pressure built up in thespace b will force the sides of the cut 5" upwards and apart to allowsaid air to escape. On completion of the filling operation the pressureis removed or replaced by a vacuum so that the sides of the cut or cutswill close in again to provide a tightly sealed assembly.

As shown in FIGURES 8, 9 and 12, the body member 1 may desirably bereduced to minimum vertical dimension thereby saving packing material.Such dimension should, however, be large enough to contain the fullamount of material which is to be contained in the final packingassembly comprising both members 1 and 3. Reducing the verticaldimension of the body member 1, moreover, has the further advantage ofproviding a readily grippable portion of sleeve member 3 projectingabove the body member 1, to expel the suppository out of the packing incase of a tendency of the suppository to stick to the body member 1. Asalready noted, expulsion out of the sleeve member 3 is easily elfectedby finger pressure' To facilitate opening the package in spite of therelatively tight clamping pressure between the two receptacles, meanssuch as an annular bead 16 (FIGURE 13) or a pair of radial lugs 17(FIGURE 14) may be provided on the upper end of slaeeve 3. Instead ofprojecting in the plane of said wall as do the lugs 17 in FIGURE 14,such lugs may be formed to project at an angle, e.g. vertically upward,therefrom; such an arrangement will at the same time further facilitateexpulsion of the contents out of the sleeve 3 by finger pressure on thelugs.

As explained in connection with the embodiments first described, packingmolds of the kind shown in FIGURES 8 to 14 may be interconnected intobunches, as shown in FIGURE 15, which shows a fragment of such a bunchincluding two individual packing molds. In the exemplary form shown inFIGURE 15 the individual packing molds are interconnected by strips 12extending in a common plane extending through the center axes of all thepacking molds, each strip portion being formed with a weak or frangiblearea 12 to facilitate separation. FIG- URE 15 also shows the sleevemembers 3 interconnected by top strips or flanges 14 extending betweenand generally coplanar with the top walls of the sleeves and also formedwith weak sections 15 aligned with the sections 13.

It will be understood that various features shown and described withreference to different embodiments may be interchanged between suchembodiments, and numerous other modifications made without departingfrom the scope and spirit of the invention.

What I claim is:

1. A packaging and molding unit comprising a main body of stiffpolystyrene being opened at one end and having an interior surface whichdefines a cylinder at said open end and a tapered closed end opposedthereto; an inner sleeve of flexible polyethylene having an interiorsurface and telescoped to a predetermined depth substantially within thecylinder of said main body, said sleeve closed only at the end opposedto said tapered closed end of said main body to thus seal said mainbody, the in terior surface of said inner sleeve being shaped to definein cooperation with said tapered end a mold cavity having anintermediate diameter larger than the diameter at either end; and aproduct such as a suppository molded to fill said cavity and removabletherefrom in said molded shape on opening said unit, the volume of saidmain body being at least as great as the volume of said product.

2. A packaging and molding unit comprising a main body being opened atone end and having an interior surface which defines a cylinder at saidopen end and a tapered closed end opposed thereto; an inner sleevehaving an interior surface and telescoped to a predetermined depthsubstantially within the cylinder of said main body, said sleeve closedonly at the end opposed to said main body, the interior surface of saidinner sleeve being shaped to define in cooperation with said tapered enda mold cavity having an intermediate diameter larger than the diameterat either end, the diameter of said inner sleeve at its open end beingslightly greater than the maximum internal diameter of said main bodywhereby said sealing of said main body by said sleeve is tight; and aproduct such as a suppository molded to fill said cavity and removabletherefrom in said molded shape on opening said unit, the volume of saidmain body being at least as great as the volume of said product.

References Cited in the file of this patent UNITED STATES PATENTS1,564,310 Jones Dec. 8, 1925 2,203,421 Stevenson June 4, 1940 2,219,181Graham Oct. 22, 1940 2,612,261 Percopo Sept. 30, 1952 2,797,805 BerardJuly 2, 1957 FOREIGN PATENTS 55,629 France May 21, 1952 (2nd add. Pat.848,960) 493,134 Belgium May 2, 1950 734,838 Great Britain Aug. 10, 19551,081,229 France June 9, 1954 1,096.474 France Feb. 2, 1955

1. A PACKAGING AND MOLDING UNIT COMPRISING A MAIN BODY OF STIFF POLYSTYRENE BEING OPENING AT ONE END AND HAVING AN INTERIOR SURFACE WHICH DEFINES A CYLINDER AT SAID OPEN END AND A TAPERED CLOSED END OPPOSED THERETO; AN INNER SLEEVE OF FLEXIBLE POLYETHYLENE HAVING AN INTERIOR SURFACE AND TELESCOPED TO A PREDETERMINED DEPTH SUBSTANTIALLY WITHIN THE CYLINDER OF SAID MAIN BODY, SAID SLEEVE CLOSED ONLY AT THE END OPPOSED TO SAID TAPERED CLOSED END OF SAID MAIN BODY TO THUS SEAL MAIN BODY, THE INTERIOR SURFACE OF SAID INNER SLEEVE BEING SHAPED TO DEFINE IN COOPERATION WITH SAID TAPERED END A MOLD CAVITY HAVING AN INTERMEDIATE DIAMETER LARGER THAN THE DIAMETER AT EITHER END; AND A PRODUCT SUCH AS A SUPPOSIITORY MOLDED TO FILL SAID CAVITY AND REMOVABLE THEREFROM IN SAID MOLDED SHAPE ON OPENING SAID UNIT, THE VOLUME OF SAID MAIN BODY BEING AT LEAST AS GREAT AS THE VOLUME OF SAID PRODUCT. 